Details for New Drug Application (NDA): 212995

NDA 212995 describes DEFERASIROX, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Norvium Bioscience, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Glenmark Speclt, Sun Pharm, Torrent, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal, and Stevens J, and is included in thirty-three NDAs. It is available from twenty suppliers. Additional details are available on the DEFERASIROX profile page.

The generic ingredient in DEFERASIROX is deferasirox. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

Summary for 212995

Tradename:	DEFERASIROX
Applicant:	Piramal
Ingredient:	deferasirox
Patents:	0

Pharmacology for NDA: 212995

Mechanism of Action

Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity

Suppliers and Packaging for NDA: 212995

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFERASIROX	deferasirox	TABLET;ORAL	212995	ANDA	Xiromed, LLC	70700-269	70700-269-30	30 TABLET in 1 BOTTLE, PLASTIC (70700-269-30)
DEFERASIROX	deferasirox	TABLET;ORAL	212995	ANDA	Xiromed, LLC	70700-270	70700-270-30	30 TABLET in 1 BOTTLE, PLASTIC (70700-270-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Dec 30, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	360MG
Approval Date:	Dec 30, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	180MG
Approval Date:	Jun 15, 2020	TE:	AB	RLD:	No

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